BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 6223609 · Received January 4, 2017

    Report

    Report Number
    3004209178-2017-00232
    Event Type
    Injury
    Date Received
    January 4, 2017
    Report Date
    February 14, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SECTION INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3889-28 LOT# V122477 SERIAL# IMPLANTED: (B)(6) 2008 EXPLANTED: (B)(6) 2015 PRODUCT TYPE LEAD . FDD C62955 APPLIES TO THE LEAD ONLY. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3889-28, LOT# V122477, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR REPORTED THAT HIS INS WAS REPLACED "ABOUT 1 YEAR AGO" ((B)(6) 2014) AND THAT ABOUT 6 WEEKS AFTER THE REPLACEMENT THE PATIENT BEGAN TO HAVE ISSUES WITH HIS LEADS. THE PATIENT REPORTED THAT BOTH THE INS AND LEADS WERE THEN REPLACED ON (B)(6) 2015. THE PATIENT HAS RECOVERED FROM THE SURGERY. NO INS MALFUNCTIONS WERE REPORTED. NO PATIENT SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT AND IT WAS REPORTED THAT THE ELECTRODE LEADS FAILED AND HAD TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7057 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention